Comparison of Patient Perceived Pain and Satisfaction Between Lightweight and Heavyweight Mesh for Laparoscopic Inguinal Hernia Repair

• Conditions: Inguinal Hernia

• Registration Number: NCT01638221
• Lead Sponsor: Ascension Health

Brief Summary

This study will be comparing the patients overall satisfaction of two different meshes used in laparoscopic inguinal hernia repairs.

Detailed Description

This is a clinical trial comparing standard therapy in the use of either lightweight or heavy mesh for the repair of inguinal hernias. Both types of these meshes have been approved for surgical correction but subjective comparisons of patient overall satisfaction and perceived outcomes have not been measured. The investigators intend to measure certain subjective data in the form of a questionnaire will be issued to the patient preoperatively, one week, one month, six months, and one year after the surgery There is no recent literature comparing subjective data between two meshes called Ultra Pro and Surgi Pro. The biological effects of these meshes have identical properties as far as the healing process and inflammation as well as the low rate of infection. The main difference is the material that these meshes are composed of. The Ultra Pro is made of Prolene while the Surgi Pro is made of polypropylene.

The risks are not increased anymore than that for normal surgical complications. They each have the same post operative risks including bleeding, infection and pain, but the investigators are investigating a possible subjective difference between these two separate meshes that are currently used.

Study Timeline

• Status Verified: 2012-07
• Study Start: 2012-07
• Study First Submitted: 2012-07-09
• Study First Submitted QC: 2012-07-10
• Study First Posted: 2012-07-11
• Last Update Submitted: 2012-07-31
• Last Update Posted: 2012-08-01
• Primary Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• over the age of 18
• unilateral side to be repaired
• no major abdominal surgery previously

Exclusion Criteria

• under age 18
• bilateral repairs undertaken

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pain	1 year	Subjective pain scale rating post surgical

Secondary Outcome Measures

Name	Time	Method
return to activities of daily living	1 year	returning to their presurgical lifestyle

Trial Locations

Locations (1)

GenesysRMC; 🇺🇸 Grand Blanc, Michigan, United States